A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Antacid; Drug: Lu AG06466 Tablet; Drug: Lu AG06466 Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028673

19270A

Details and patient eligibility

About

The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.

Full description

This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m^2 at the Screening Visit and at the Baseline Visit.
• The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit.

Exclusion criteria

• The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses).
• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Lu AG06466 Capsule, Fasted State

Experimental group

Description:

Participants will receive 1 capsule of Lu AG06466 in a fasted state.

Treatment:

Drug: Lu AG06466 Capsule

Lu AG06466 Tablet, Fasted State

Experimental group

Description:

Participants will receive 1 tablet of Lu AG06466 in a fasted state.

Treatment:

Drug: Lu AG06466 Tablet

Lu AG06466 Tablet, Fed State

Experimental group

Description:

Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal).

Treatment:

Drug: Lu AG06466 Tablet

Lu AG06466 Tablet + Antacid, Fasted State

Experimental group

Description:

Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state.

Treatment:

Drug: Antacid

Drug: Lu AG06466 Tablet